Drug product
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
D-0011-2016
Product summary
- Event
- Event 72234
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,110 bottles
- Official record key
drug-enforcement:D-0011-2016
Official wording
Reason: CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Code information: Lot #: 559660P, 559661P, Exp 03/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations